Tissue and organ transplantation is a rapidly growing therapeutic field as a result of improvements in surgical procedures, advancements in immunosuppressive drugs and increased knowledge of graft/host interaction. There are numerous investigations underway directed toward the engineering of improved transplantable tissue grafts, however, it is generally believed in the industry that ideal implants have yet to be produced.
The use of decellularized tissue scaffolds have been explored as a possibility for tissue engineering, however, the existing approaches have proven inadequate. References of interest include U.S. Pat. No. 6,743,574; U.S. Pat. No. 5,336,616; Gratzer et al., Tissue Engineering, 12(10):2975-2983 (2006); Woods et al., Biomaterials, 26:7339-7349 (2005); Williams et al., Acta Biomaterialia, 5:993-1005 (2009); Liao et al., Biomaterials, 29:1065-1074 (2008); Wilson et al., Ann Thorac Surg, 60:S353-S358 (1995); PCT App. Pub. No. WO2006/101885; U.S. Pat. No. 7,318,998; Kitagawa et al., J Med Invest, 48(3-4):123-132 (2001); Kearney, Clin Dermatol, 23:357-364 (2005); Azar, Clin Sport Med, 28:191-201 (2009); and Simon et al., Eur J Cardiothorac Surg, 23:1002-1006 (2003)).
Despite major advancements in the field of biomedical engineering, modern tissue transplantation remains associated with complications including inflammation, degradation, scarring, contracture, calcification (hardening), occlusion, and/or rejection. Moreover, existing technologies for producing decellularized tissue scaffolds have failed to sufficiently reduce the number of cells in the tissue to an adequate level. Therefore, there is a need in the art for methods of producing tissues that avoid or reduce the above-described drawbacks and thus have greater short- and long-term usability. There is also a further need in the art for methods of producing sterile, decellularized tissues.